Lung Cancer
Conditions
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Brief summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, also work in different ways to kill tumor cells or stop them from growing. Giving bevacizumab together with docetaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel works in treating older patients with stage III or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES: Primary * To determine the proportion of elderly (≥ 75 years of age) patients with stage III or IV non-small cell lung cancer surviving for at least 6 months when treated with a combination of bevacizumab and weekly docetaxel. Secondary * To assess the progression-free and overall survival of patients treated with this regimen. * To determine the response rate in patients treated with this regimen. * To assess the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV on days 1, 8, and 15. Treatment may repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 4 weeks.
Interventions
BIOLOGICALbevacizumab
Avastin 10.0 mg/kg on days 1 and 15
DRUGdocetaxel
Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
Sponsors
National Cancer Institute (NCI)
Barbara Ann Karmanos Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically or cytologically confirmed non-small cell lung cancer * Stage III or IV disease * Stage III disease allowed, provided the patient is not a candidate for concurrent chemotherapy and radiotherapy * Mixed histology allowed, provided the biopsy has less than 50% squamous cell histology * Measurable or evaluable disease
Exclusion criteria
* Squamous cell histology * Evidence of cavitation in the tumor * Tumors in close proximity to major blood vessels * No active, untreated brain metastases * More than 7 days since prior treatment for brain metastases AND no evidence of hemorrhage in the lesion * Stable or declining dose of steroids allowed PATIENT CHARACTERISTICS: Inclusion criteria: * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * Life expectancy \> 12 weeks * Leukocytes ≥ 3,000/μL * Absolute neutrophil count ≥ 1,500/μL * Platelet count ≥ 100,000/μL * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN (\< 5 times ULN if patients has liver metastases) * Creatinine ≤ 1.5 times normal * Left ventricular function ≥ normal by MUGA scan or ECHO * Urine protein:creatinine ratio ≤ 1.0 AND/OR urine protein ≤ 1+ by dipstick analysis OR protein ≤ 1 g/24-hour urine collection * Fertile patients must use effective contraception and women should avoid breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival | 6 months when treated with combination of Avastin and weekly docetaxel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 6 months when treated with combination of Avastin and weekly docetaxel | Progression-free survival in months via the Kaplan-Meier method |
| Overall Survival | 4 weeks after removal from study or until death | Overall survival using Kaplan-Meier method. |
| Response Rate | Every 8 weeks | — |
| Toxicity According to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | 1st and 2nd week of each 21 day cycle, up to six cycles. | Toxicity: using the highest grade of each toxicity experienced by each patient according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Avastin & Docetaxel Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
bevacizumab: Avastin 10.0 mg/kg on days 1 and 15
docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15 | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible | 3 |
Baseline characteristics
| Characteristic | Avastin & Docetaxel |
|---|---|
| Age, Continuous | 79.7 years STANDARD_DEVIATION 4.15 |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 8 |
| serious Total, serious adverse events | 3 / 8 |
Outcome results
Primary
Survival
Time frame: 6 months when treated with combination of Avastin and weekly docetaxel
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Avastin & Docetaxel | Survival | 75 percentage of participants surviving |
Secondary
Overall Survival
Overall survival using Kaplan-Meier method.
Time frame: 4 weeks after removal from study or until death
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Avastin & Docetaxel | Overall Survival | 35.7 months |
Secondary
Progression-free Survival
Progression-free survival in months via the Kaplan-Meier method
Time frame: 6 months when treated with combination of Avastin and weekly docetaxel
Population: No patient showed a response, therefore all patients had 0 for PFS
Secondary
Response Rate
Time frame: Every 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Avastin & Docetaxel | Response Rate | 0 Participants |
Secondary
Toxicity According to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Toxicity: using the highest grade of each toxicity experienced by each patient according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time frame: 1st and 2nd week of each 21 day cycle, up to six cycles.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Avastin & Docetaxel | Toxicity According to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Serious (grade 3 or 4) | 21 Adverse event |
| Avastin & Docetaxel | Toxicity According to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | other (grade 0, 1, or 2) | 123 Adverse event |